Stroke Happens

Stroke is an unpredictable and devastating event which is under diagnosed and under reported in TAVR, as well as in Surgical Aortic Valve Replacement (SAVR).

The majority of TAVR stroke is peri-procedural. Cerebrovascular events as a result of TAVR are shown to occur most frequently at Day 0-1, with the median time to major stroke being 1 day. More than 50% of identified strokes are classified as major, with more than 95% of those being ischemic.1, 4

In the SENTINEL trial, prospective assessment by neurologists revealed a 30-day all-stroke rate in unprotected TAVR of 9.1%.2 In other words, almost 1 in 10 TAVR patients show overt signs of ischemic brain injury as a result of the procedure.

The American Association of Neurological Surgeons (AANS) and Society of NeuroInterventional Surgery (SNIS) have endorsed the key role of Sentinel CPS in the reduction of stroke during TAVR.

Protection Works

Protected TAVR™ with Claret Medical’s Sentinel® gives you the power to reduce stroke.  In the SENTINEL pivotal US IDE, peri-procedural stroke rate was reduced by 63%4 when Sentinel CPS was used.

The 63% reduction was confirmed in an independent real-world academic study from Ulm Germany, which demonstrated compelling 70% reduction in neurologist adjudicated TAVR Stroke, and Stroke or Mortality in the first 7-days post TAVR.

Click here to read a study in Journal of American College of Cardiology (JACC) that underscores how Sentinel CPS reduces TAVR 7-Day All-Stroke  and 7-Day All-Stroke or All-Cause Mortality by 70%.5

Cerebral Damage More Pervasive Than Originally Thought

When neurologists examine TAVR patients’ brains post-procedure, they are seeing more damage than has been reported to-date. Neurological deficit has been observed in 28% of TAVR patients that did not receive cerebral protection as evaluated by a neurologist two days post-procedure. In addition, protected patients have shown a significantly lower ataxia* rate when compared to unprotected patients (9% vs. 24%, respectively) two days post-procedure.4

Past clinical studies on surgical valve replacement have reported stroke rates as determined by cardiovascular surgeons. When neurologists are part of the Heart Team that clinically examines the patient following surgery, clinical stroke is reported more frequently than previously thought. A de novo surgical aortic valve replacement study found that the surgeon-reported stroke rate was 6.6%, which rose to 17% upon clinical and MRI review by a neurologist.5

*Ataxia is a lack of coordination and steadiness of muscle movement most often associated with damage to the brain.

References:

  1. Tchétché, et al. J Am Coll Cardiol Intv. 2014;7(10):1138-45.
  2. Kapadia S, Kodali S, Makkar R, et al. Protection against cerebral embolism during transcatheter aortic valve replacement. JACC. 2017;69(4): 367-377.
  3. Nombela-Franco, et. al. Circulation. 2012;126:3041-53.
  4. U.S. IFU click here.
  5. Seeger, J. et. al. in press. JACC 2017 September.
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